MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-04-13 for SPIROPERFECT SPIROPERFECT USB manufactured by Medikro Oy.
[2632942]
Welch allyn (b)(6) rec'd a complaint against the spirometer flow transducer, welch allyn part number 703419, on (b)(6) 2011. Welch allyn became aware through a distributor (b)(4) that their customer experienced a problem with the flow transducers. Twice when she wanted a pt to inhale to start the spirometer measurements a foreign object ended up in the pt's mouth. There were no injuries as a result of these event and no report of the object going into the pt's windpipe/trachea. Welch allyn contacted the complainant and requested the devices to be returned for further eval. If welch allyn will receive the devices, they will forward them to (b)(6) for further eval. To this day (b)(6) 2011, (b)(4) has not rec'd the devices. Welch allyn has informed fda about this complaint.
Patient Sequence No: 1, Text Type: D, B5
[9849346]
The spirosafe flow transducer is a one piece construction and it does not have any moving parts. It is a single-use only product and if it has been used more than once (b)(4) cannot guarantee its functionality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2011-00016 |
| MDR Report Key | 2575140 |
| Report Source | 08 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-04-07 |
| Date of Event | 2011-02-10 |
| Report Date | 2011-04-07 |
| Date Mfgr Received | 2011-03-09 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | KELLOLAHDENTIE 27 |
| Manufacturer City | KUOPIO FI-70460 |
| Manufacturer Country | FI |
| Manufacturer Postal | FI-70460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIROPERFECT |
| Generic Name | DIAGNOSTIC SPIROMETER |
| Product Code | BZG |
| Date Received | 2011-04-13 |
| Model Number | SPIROPERFECT USB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIKRO OY |
| Manufacturer Address | KUOPIO FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-13 |